Major Depressive Disorder
CNS 3 original drugsMarket Leaders
Phase 3 Readouts Pro
12 active Phase 3 trials with confidence-graded completion dates.
Anchored on CT.gov primary completion date. Topline announcements typically precede this by 3–9 months. Confidence labels combine date type (ACTUAL/ESTIMATED) with last-update freshness.
Treatments by Mechanism
Top 10 mechanisms across 32 industry trials with a known mechanism of action.
MoA derived from FDA pharmClassEpc when intervention matches an approved drug. Codenamed clinical-stage assets without an approved counterpart show "—" and aren't grouped here — they're still in the phase tables below.
Clinical Pipeline by Phase
638 industry-sponsored trials across 169 sponsors
| Sponsor | Asset | MoA | Status | Primary Completion | NCT |
|---|---|---|---|---|---|
| Neurocrine Biosciences | Valbenazine | — | RECRUITING | 2027-01 | NCT07105111 |
| Janssen Korea, Ltd., Korea | Esketamine 56 mg | — | RECRUITING | 2027-06-25 | NCT07053345 |
| Axsome Therapeutics, Inc. | AXS-05 | — | RECRUITING | 2026-03 | NCT06223880 |
| Luye Pharma Group Ltd. | Toludesvenlafaxine Hydrochloride Sustained-release Tablets | — | NOT YET RECRUITING | 2027-02-28 | NCT06426485 |
| Bausch Health Americas, Inc. | bupropion hydrobromide | Dopamine transporter/Norepinephrine transporter | NOT YET RECRUITING | 2029-07 | NCT02129751 |
| Neurocrine Biosciences | Valbenazine | — | COMPLETED | 2024-12-27 | NCT05859698 |
| Johnson & Johnson | Esketamine | — | COMPLETED | 2024-07-22 | NCT04829318 |
| Johnson & Johnson | Esketamine 56 mg | — | COMPLETED | 2024-01-31 | NCT04599855 |
| AbbVie | — | — | COMPLETED | 2022-12-06 | NCT04390581 |
| Teva Branded Pharmaceutical Products R&D, Inc. | Fremanezumab | — | COMPLETED | 2022-08-31 | NCT04041284 |
| Supernus Pharmaceuticals, Inc. | ZULRESSO® | — | COMPLETED | 2022-07-14 | NCT05059600 |
| H. Lundbeck A/S | Vortioxetine | — | COMPLETED | 2022-07-06 | NCT04294654 |
| Field Trip Health | — | — | COMPLETED | 2022-06-16 | NCT05604794 |
| Otsuka Pharmaceutical Development & Commercialization, Inc. | Brexpiprazole | Atypical Antipsychotic [EPC] | COMPLETED | 2022-05-27 | NCT04830215 |
| H. Lundbeck A/S | Vortioxetine | — | COMPLETED | 2022-02-11 | NCT04288895 |
| H. Lundbeck A/S | Vortioxetine | — | COMPLETED | 2022-01-06 | NCT04448431 |
| Brainsway | — | — | COMPLETED | 2020-07-01 | NCT04679753 |
| H. Lundbeck A/S | Vortioxetine | — | COMPLETED | 2020-02-21 | NCT03835715 |
| Takeda | Vortioxetine | — | COMPLETED | 2019-03-01 | NCT02371980 |
| The Taub Group | Scopolamine and naltrexone | — | COMPLETED | 2018-11-20 | NCT03386448 |
| Assurex Health Inc. | — | — | COMPLETED | 2018-11 | NCT02466477 |
| Takeda | Vortioxetine | — | COMPLETED | 2018-02-06 | NCT02972632 |
| Takeda | Ramelteon | Melatonin Receptor Agonist [EPC] | COMPLETED | 2018-01-31 | NCT02669082 |
| Lundbeck Canada Inc. | vortioxetine | — | COMPLETED | 2017-07-06 | NCT02332954 |
| AbbVie | — | — | COMPLETED | 2016-12-14 | NCT02980783 |
| Forest Laboratories | Levomilnacipran ER | — | COMPLETED | 2016-09-16 | NCT02288325 |
| Xian-Janssen Pharmaceutical Ltd. | Escitalopram | — | COMPLETED | 2015-05 | NCT01870843 |
| Forest Laboratories | Vilazodone | — | COMPLETED | 2014-10 | NCT01573598 |
| Forest Laboratories | Vilazodone | — | COMPLETED | 2013-06 | NCT01473381 |
| Taiwan Otsuka Pharm. Co., Ltd | Aripiprazole | Atypical Antipsychotic [EPC] | COMPLETED | 2013-05 | NCT01429831 |
| Eli Lilly | Duloxetine | — | COMPLETED | 2013-03 | NCT01051466 |
| Forest Laboratories | Vilazodone | — | COMPLETED | 2013-02 | NCT01473394 |
| Forest Laboratories | Escitalopram | — | COMPLETED | 2013-01 | NCT01198795 |
| Pfizer | desvenlafaxine succinate sustained-release 50 mg/day | — | COMPLETED | 2012-07 | NCT01432457 |
| Pfizer | varenicline | — | COMPLETED | 2012-06 | NCT01078298 |
| Xian-Janssen Pharmaceutical Ltd. | Escitalopram | — | COMPLETED | 2012-02 | NCT01814085 |
| Pfizer | desvenlafaxine succinate sustained-release | — | COMPLETED | 2011-06 | NCT01121484 |
| Xian-Janssen Pharmaceutical Ltd. | Escitalopram | — | COMPLETED | 2011-05-31 | NCT01814098 |
| Eli Lilly | Duloxetine | — | COMPLETED | 2011-03 | NCT01070329 |
| Eli Lilly | Duloxetine hydrochloride | — | COMPLETED | 2011-02 | NCT00960986 |
| Pfizer | Desvenlafaxine Succinate Sustained-Release Formulation 50 mg | — | COMPLETED | 2011-02 | NCT01056289 |
| Eli Lilly | Duloxetine | — | COMPLETED | 2010-12 | NCT00985504 |
| Eli Lilly | Duloxetine | — | COMPLETED | 2010-10 | NCT01000805 |
| Pfizer | Desvenlafaxine Succinate Sustained Release | — | COMPLETED | 2010-08 | NCT00952653 |
| Nang Kuang Pharmaceutical Co., Ltd. | Smilon® | — | COMPLETED | 2010-08 | NCT01119924 |
| Boehringer Ingelheim | Duloxetine 60 mg QD | — | COMPLETED | 2010-06 | NCT00844194 |
| Eli Lilly | Duloxetine Hydrochloride | — | COMPLETED | 2010-02 | NCT00810069 |
| Wyeth is now a wholly owned subsidiary of Pfizer | — | — | COMPLETED | 2009-07 | NCT00788944 |
| Eli Lilly | Duloxetine | — | COMPLETED | 2009-07 | NCT00696774 |
| Eli Lilly | duloxetine | — | COMPLETED | 2009-02 | NCT00666757 |
| Otsuka Pharmaceutical Development & Commercialization, Inc. | Aripiprazole or other oral antipsychotics | — | TERMINATED | 2018-10-17 | NCT03643159 |
| Novartis | Venlafaxine | — | TERMINATED | 2013-09 | NCT01436643 |
| GSK | paroxetine 10mg tablet | — | TERMINATED | 2011-02 | NCT00812812 |
| Rafa Laboratories | hypericum | — | TERMINATED | 2010-11 | NCT00557427 |
| Alto Neuroscience | Sertraline | — | WITHDRAWN | 2023-05-30 | NCT04388202 |
| Alto Neuroscience | Duloxetine | — | WITHDRAWN | 2023-05-30 | NCT04388189 |
| Otsuka Pharmaceutical Development & Commercialization, Inc. | Brexpiprazole | Atypical Antipsychotic [EPC] | WITHDRAWN | 2023-03-22 | NCT05504486 |
| Sage Therapeutics | Brexanolone | — | WITHDRAWN | 2021-08 | NCT04273191 |
| GSK | Paroxetine CR | — | WITHDRAWN | 2014-09 | NCT01916200 |
| Wyeth is now a wholly owned subsidiary of Pfizer | Effexor XR | NET/SERT | WITHDRAWN | 2011-10 | NCT00878748 |
| Sponsor | Asset | MoA | Status | Primary Completion | NCT |
|---|---|---|---|---|---|
| Cybin IRL Limited | CYB003 | — | RECRUITING | 2026-08 | NCT06564818 |
| Xenon Pharmaceuticals Inc. | Azetukalner | — | RECRUITING | 2026-08 | NCT06775379 |
| Intra-Cellular Therapies, Inc. | Lumateperone | — | RECRUITING | 2026-09 | NCT05850689 |
| CSPC Ouyi Pharmaceutical Co., Ltd. | Dextromethorphan and Bupropion Sustained-Release Tablets | — | RECRUITING | 2026-09-30 | NCT06958692 |
| Johnson & Johnson | Seltorexant | — | RECRUITING | 2026-12-30 | NCT06559306 |
| AbbVie | Cariprazine | — | RECRUITING | 2027-03 | NCT04777357 |
| Cybin IRL Limited | CYB003 | — | RECRUITING | 2027-03-18 | NCT06793397 |
| Xenon Pharmaceuticals Inc. | Azetukalner | — | RECRUITING | 2027-05 | NCT07076407 |
| Neumora Therapeutics, Inc. | NMRA-335140 | — | RECRUITING | 2027-06 | NCT06029439 |
| Sunshine Lake Pharma Co., Ltd. | Mitizodone Phosphate tablets | — | RECRUITING | 2027-07 | NCT04984512 |
| Neurocrine Biosciences | NBI-1065845 | — | RECRUITING | 2027-07 | NCT06963021 |
| Neurocrine Biosciences | NBI-1065845 | — | RECRUITING | 2027-07 | NCT06911112 |
| Neurocrine Biosciences | NBI-1065845 | — | RECRUITING | 2027-07 | NCT06786624 |
| Definium Therapeutics US, Inc. | DT120 | — | RECRUITING | 2027-09 | NCT07592689 |
| Eli Lilly | Brenipatide | — | RECRUITING | 2028-02 | NCT07412756 |
| Vanda Pharmaceuticals | Milsaperidone | — | RECRUITING | 2028-03 | NCT06830044 |
| Neurocrine Biosciences | NBI-1065845 | — | RECRUITING | 2028-07 | NCT07196501 |
| Johnson & Johnson | Seltorexant | — | RECRUITING | 2028-08-24 | NCT07573176 |
| Axsome Therapeutics, Inc. | Solriamfetol 150 MG | — | RECRUITING | 2028-12 | NCT07484217 |
| Neurocrine Biosciences | NBI-1065845 | — | RECRUITING | 2029-05 | NCT06966401 |
| Takeda | Vortioxetine tablets | — | RECRUITING | 2029-09-30 | NCT07204314 |
| Johnson & Johnson | Esketamine | — | RECRUITING | 2031-04-09 | NCT07227454 |
| Korea Otsuka Pharmaceutical Co., Ltd. | Abilify 2, 5, 10, 15mg (Tablet) | — | RECRUITING | 2025-11 | NCT03423680 |
| Definium Therapeutics US, Inc. | MM120 (LSD D-Tartrate) | — | ACTIVE NOT RECRUITING | 2026-11 | NCT06941844 |
| Neumora Therapeutics, Inc. | NMRA-335140 | — | ACTIVE NOT RECRUITING | 2026-05 | NCT06058039 |
| Neumora Therapeutics, Inc. | NMRA-335140 | — | ACTIVE NOT RECRUITING | 2026-05 | NCT06058013 |
| COMPASS Pathways | Psilocybin | — | ACTIVE NOT RECRUITING | 2026-02 | NCT05711940 |
| COMPASS Pathways | Psilocybin | — | ACTIVE NOT RECRUITING | 2025-05-28 | NCT05624268 |
| CSPC ZhongQi Pharmaceutical Technology Co., Ltd. | Ammoxetine | — | NOT YET RECRUITING | 2026-06-30 | NCT06827431 |
| Tasly Pharmaceutical Group Co., Ltd | JS1-1-01 low-dose group | — | NOT YET RECRUITING | 2026-12-31 | NCT07485595 |
| NeuroRx, Inc. | NRX-101 | — | NOT YET RECRUITING | 2026-12-31 | NCT07227103 |
| Lipocine Inc. | LPCN 1154A | — | COMPLETED | 2026-01-16 | NCT06979544 |
| Zhejiang Huahai Pharmaceutical Co., Ltd. | Levomilnacipran Hydrochloride Extended-Release Capsules | — | COMPLETED | 2025-06-13 | NCT07253207 |
| Axsome Therapeutics, Inc. | Solriamfetol 300 mg | — | COMPLETED | 2024-12-31 | NCT06360419 |
| Neumora Therapeutics, Inc. | NMRA-335140 | — | COMPLETED | 2024-12-03 | NCT06029426 |
| Johnson & Johnson | Aticaprant | — | COMPLETED | 2024-11-08 | NCT05550532 |
| Intra-Cellular Therapies, Inc. | Lumateperone | — | COMPLETED | 2024-10-14 | NCT05061719 |
| Johnson & Johnson | Aticaprant | — | COMPLETED | 2024-09-18 | NCT05455684 |
| Intra-Cellular Therapies, Inc. | Lumateperone | — | COMPLETED | 2024-04-12 | NCT05061706 |
| Intra-Cellular Therapies, Inc. | Lumateperone | — | COMPLETED | 2024-02-22 | NCT04985942 |
| Johnson & Johnson | Seltorexant | — | COMPLETED | 2023-10-03 | NCT04513912 |
| Relmada Therapeutics, Inc. | REL-1017 | — | COMPLETED | 2023-07-27 | NCT04855760 |
| Biogen | SAGE-217 | — | COMPLETED | 2023-06-22 | NCT03864614 |
| Janssen-Cilag, S.A. | Esketamine | — | COMPLETED | 2023-06-16 | NCT04476446 |
| Johnson & Johnson | Seltorexant | — | COMPLETED | 2023-04-25 | NCT04533529 |
| Johnson & Johnson | Esketamine Nasal Spray | — | COMPLETED | 2022-12-30 | NCT02782104 |
| Intra-Cellular Therapies, Inc. | Lumateperone | — | COMPLETED | 2022-11-30 | NCT04285515 |
| Relmada Therapeutics, Inc. | REL-1017 | — | COMPLETED | 2022-11-01 | NCT04688164 |
| Relmada Therapeutics, Inc. | REL-1017 | — | COMPLETED | 2022-09-13 | NCT05081167 |
| AbbVie | Cariprazine | — | COMPLETED | 2022-09-05 | NCT03573297 |
| Mochida Pharmaceutical Company, Ltd. | Desvenlafaxine 100 mg | — | COMPLETED | 2022-07-21 | NCT04345471 |
| Otsuka Pharmaceutical Development & Commercialization, Inc. | Brexpiprazole | Atypical Antipsychotic [EPC] | COMPLETED | 2022-07-08 | NCT03538691 |
| Otsuka Pharmaceutical Co., Ltd. | Brexpiprazole | Atypical Antipsychotic [EPC] | COMPLETED | 2022-06-06 | NCT03697603 |
| Praxis Precision Medicines | PRAX-114 | — | COMPLETED | 2022-05-05 | NCT04832425 |
| Biogen | SAGE-217 | — | COMPLETED | 2022-03-15 | NCT04442503 |
| H. Lundbeck A/S | Vortioxetine 10 mg/day | — | COMPLETED | 2022-01-21 | NCT02709655 |
| Janssen-Cilag International NV | Esketamine 28 mg | — | COMPLETED | 2022-01-20 | NCT04338321 |
| Biogen | SAGE-217 | — | COMPLETED | 2021-10-25 | NCT04476030 |
| AbbVie | Cariprazine | — | COMPLETED | 2021-09-30 | NCT03738215 |
| CSPC ZhongQi Pharmaceutical Technology Co., Ltd. | Duloxetine Hydrochloride Enteric-coated Capsule | — | COMPLETED | 2021-09-22 | NCT04364997 |
| AbbVie | Cariprazine | — | COMPLETED | 2021-09-06 | NCT03739203 |
| Johnson & Johnson | Esketamine 56 mg | — | COMPLETED | 2021-04-13 | NCT03434041 |
| Biogen | SAGE-217 | — | COMPLETED | 2021-03-26 | NCT04442490 |
| Otsuka Pharmaceutical Co., Ltd. | Brexpiprazole | Atypical Antipsychotic [EPC] | COMPLETED | 2021-03-17 | NCT03737474 |
| AbbVie | Levomilnacipran ER | — | COMPLETED | 2021-03-01 | NCT03569475 |
| Supernus Pharmaceuticals, Inc. | Brexanolone | — | COMPLETED | 2021-01-08 | NCT03665038 |
| Luye Pharma Group Ltd. | LY03005 extended-release tablet | — | COMPLETED | 2020-12-24 | NCT04853407 |
| Axsome Therapeutics, Inc. | AXS-05 (dextromethorphan and bupropion) oral tablets | — | COMPLETED | 2020-10-23 | NCT04039022 |
| ACADIA Pharmaceuticals Inc. | Pimavanserin | — | COMPLETED | 2020-04-30 | NCT03968159 |
| H. Lundbeck A/S | Vortioxetine | — | COMPLETED | 2020-04-16 | NCT03108625 |
| Axsome Therapeutics, Inc. | AXS-05 | — | COMPLETED | 2020-03-20 | NCT02741791 |
| Alkermes, Inc. | ALKS 5461 | — | COMPLETED | 2020-02-26 | NCT03188185 |
| Axsome Therapeutics, Inc. | AXS-05 | — | COMPLETED | 2019-11-26 | NCT04019704 |
| Shionogi | Duloxetine Hydrochloride | — | COMPLETED | 2019-11-08 | NCT03315793 |
| Biogen | SAGE-217 | — | COMPLETED | 2019-09-24 | NCT03672175 |
| Forest Laboratories | Levomilnacipran | — | COMPLETED | 2019-08-19 | NCT02431806 |
| H. Lundbeck A/S | Vortioxetine 10 mg/day | — | COMPLETED | 2019-07-02 | NCT02709746 |
| Johnson & Johnson | Esketamine | — | COMPLETED | 2019-04-11 | NCT03097133 |
| Naurex, Inc, an affiliate of Allergan plc | Rapastinel | — | COMPLETED | 2019-02-22 | NCT02951988 |
| Johnson & Johnson | Esketamine | — | COMPLETED | 2018-12-18 | NCT03039192 |
| Naurex, Inc, an affiliate of Allergan plc | Rapastinel | — | COMPLETED | 2018-12-12 | NCT02943564 |
| Naurex, Inc, an affiliate of Allergan plc | Rapastinel | — | COMPLETED | 2018-12-06 | NCT03002077 |
| Biogen | SAGE-217 15/20 mg Oral Solution | — | COMPLETED | 2018-11-15 | NCT02978326 |
| Naurex, Inc, an affiliate of Allergan plc | Rapastinel | — | COMPLETED | 2018-10-26 | NCT02943577 |
| Naurex, Inc, an affiliate of Allergan plc | Rapastinel | — | COMPLETED | 2018-09-21 | NCT02932943 |
| Forest Laboratories | Vilazodone | — | COMPLETED | 2018-09-11 | NCT02372799 |
| Forest Laboratories | Vilazodone | — | COMPLETED | 2018-07-23 | NCT02436239 |
| Takeda | Vortioxetine | — | COMPLETED | 2018-03-16 | NCT02389816 |
| Johnson & Johnson | Esketamine | — | COMPLETED | 2018-02-20 | NCT02417064 |
| Johnson & Johnson | Esketamine | — | COMPLETED | 2018-02-15 | NCT02493868 |
| Forest Laboratories | Cariprazine | — | COMPLETED | 2018-01-18 | NCT02670538 |
| Alkermes, Inc. | ALKS 5461 | — | COMPLETED | 2017-11-20 | NCT02141399 |
| Johnson & Johnson | Esketamine (Intranasal Spray) | — | COMPLETED | 2017-10-28 | NCT02497287 |
| Supernus Pharmaceuticals, Inc. | SAGE-547 60 μg/kg/h | — | COMPLETED | 2017-09-24 | NCT02942004 |
| Supernus Pharmaceuticals, Inc. | SAGE-547 90 μg/kg/h | — | COMPLETED | 2017-09-17 | NCT02942017 |
| Johnson & Johnson | Esketamine | — | COMPLETED | 2017-08-10 | NCT02422186 |
| Forest Laboratories | Cariprazine | — | COMPLETED | 2017-07-19 | NCT02670551 |
| Johnson & Johnson | Esketamine | — | COMPLETED | 2017-06-01 | NCT02418585 |
| Otsuka Pharmaceutical Development & Commercialization, Inc. | OPC-34712 | — | COMPLETED | 2017-04-18 | NCT01360866 |
| Ybrain Inc. | — | — | COMPLETED | 2016-12 | NCT02657980 |
| Sponsor | Asset | MoA | Status | Primary Completion | NCT |
|---|---|---|---|---|---|
| Sichuan Purity Pharmaceutical Technology Co., Ltd. | Low Dose PRT042 nasal spray | — | RECRUITING | 2026-06 | NCT07193901 |
| Autobahn Therapeutics, Inc. | ABX-002 | — | RECRUITING | 2026-06 | NCT06633016 |
| Johnson & Johnson | JNJ-89495120 | — | RECRUITING | 2026-06-26 | NCT06785012 |
| atai Therapeutics, Inc. | VLS-01-203 BU | — | RECRUITING | 2026-08-01 | NCT06524830 |
| Gilgamesh Pharmaceuticals | GM-2505 | — | RECRUITING | 2026-10 | NCT06236880 |
| Beckley Psytech Limited | BPL-003 | — | RECRUITING | 2026-11 | NCT05660642 |
| Alto Neuroscience | ALTO-300 | — | RECRUITING | 2026-12 | NCT05922878 |
| Mapi Pharma Ltd. | Cariprazine Depot | — | RECRUITING | 2026-12-31 | NCT07185815 |
| Supernus Pharmaceuticals, Inc. | SPN-821 2400 mg | — | RECRUITING | 2026-12-31 | NCT07226661 |
| Seaport Therapeutics | SPT-300 | — | RECRUITING | 2027-03 | NCT07065240 |
| ACADIA Pharmaceuticals Inc. | ACP-211 | — | RECRUITING | 2027-08 | NCT07284667 |
| Draig Therapeutics Ltd | DT-101 | — | RECRUITING | 2027-08 | NCT07300969 |
| AbbVie | Icalcaprant | — | RECRUITING | 2027-09 | NCT07276997 |
| Syndeio Biosciences, Inc | Zelquistinel | — | RECRUITING | 2027-09 | NCT06547489 |
| Alto Neuroscience | ALTO-207 | — | RECRUITING | 2027-11 | NCT07553637 |
| Syndeio Biosciences, Inc | Zelquistinel | — | RECRUITING | 2028-03-30 | NCT07115329 |
| Hangzhou PhecdaMed Co., Ltd. | TJ0113 | — | RECRUITING | 2026-05-25 | NCT07018245 |
| Autobahn Therapeutics, Inc. | ABX-002 | — | RECRUITING | 2026-02-27 | NCT06869187 |
| Sirtsei Pharmaceuticals, Inc. | SP-624 | — | ACTIVE NOT RECRUITING | 2026-07-15 | NCT06254612 |
| Ono Pharmaceutical Co., Ltd. | ONO-1110 | — | ACTIVE NOT RECRUITING | 2026-08-31 | NCT06792136 |
| Chase Therapeutics Corporation | CTC-501 | — | ACTIVE NOT RECRUITING | 2025-12-30 | NCT03642964 |
| Eleusis Therapeutics | ELE-101 | — | ACTIVE NOT RECRUITING | 2025-12 | NCT05434156 |
| Nanjing Minova Pharmaceutical Co., Ltd. | MI078 capsule dose 1 | — | ACTIVE NOT RECRUITING | 2025-10 | NCT06963580 |
| COMPASS Pathways | Psilocybin | — | ACTIVE NOT RECRUITING | 2025-09 | NCT05733546 |
| Chengdu Kanghong Pharmaceutical Group Co., Ltd. | KH607 tablet | — | NOT YET RECRUITING | 2027-01 | NCT07096791 |
| Afasci Inc | AFA-281 | — | NOT YET RECRUITING | 2027-06-01 | NCT06710431 |
| Enalare Therapeutics Inc. | ENA-001 | — | NOT YET RECRUITING | 2027-06-15 | NCT06137638 |
| BioLite, Inc. | PDC-1421 Capsule | — | NOT YET RECRUITING | 2028-02-28 | NCT03833206 |
| Soterix Medical | — | — | NOT YET RECRUITING | 2028-06-01 | NCT07287839 |
| Chengdu Kanghong Pharmaceutical Group Co., Ltd. | KH607 tablets | — | NOT YET RECRUITING | 2025-12 | NCT07101120 |
| Biohaven Therapeutics Ltd. | BHV-7000 | — | COMPLETED | 2026-03-18 | NCT06423781 |
| Suven Life Sciences Limited | Ropanicant | — | COMPLETED | 2026-02-23 | NCT06836063 |
| Biohaven Therapeutics Ltd. | BHV-7000 | — | COMPLETED | 2025-11-07 | NCT06419608 |
| Otsuka Pharmaceutical Development & Commercialization, Inc. | SEP-363856 | — | COMPLETED | 2025-11-06 | NCT05593029 |
| DuKang Pharmaceuticals, Inc. | NORA520 Dose 1 | — | COMPLETED | 2025-09-11 | NCT06285916 |
| Jiangsu Nhwa Pharmaceutical Co., Ltd. | NH102 | — | COMPLETED | 2025-07-30 | NCT06842992 |
| Neurocrine Biosciences | NBI-1070770 | — | COMPLETED | 2025-07-25 | NCT06267846 |
| Clexio Biosciences Ltd. | CLE-100 | — | COMPLETED | 2025-06-06 | NCT06340958 |
| Reunion Neuroscience Inc | RE104 for Injection | — | COMPLETED | 2025-05-22 | NCT06342310 |
| Otsuka Pharmaceutical Development & Commercialization, Inc. | Centanafadine | — | COMPLETED | 2025-05-16 | NCT05536414 |
| Boehringer Ingelheim | BI 1569912 | — | COMPLETED | 2025-05-02 | NCT06558344 |
| Alto Neuroscience | ALTO-203 25 μg | — | COMPLETED | 2025-04-14 | NCT06391593 |
| Beckley Psytech Limited | BPL-003 | — | COMPLETED | 2025-03-28 | NCT05870540 |
| Gilgamesh Pharmaceuticals | GM-1020 | — | COMPLETED | 2025-03-04 | NCT06309277 |
| Boehringer Ingelheim | BI 1569912 | — | COMPLETED | 2025-02-26 | NCT06280235 |
| Biomind Labs Inc. | Sublingual administration | — | COMPLETED | 2025-02-15 | NCT06812221 |
| Navitor Pharmaceuticals, Inc. | NV-5138 | — | COMPLETED | 2025-01-21 | NCT05066672 |
| Mapreg | MAP4343 | — | COMPLETED | 2024-11-07 | NCT03870776 |
| Tasly Pharmaceutical Group Co., Ltd | JS1-1-01 low-dose group | — | COMPLETED | 2024-10-23 | NCT06259526 |
| GH Research Ireland Limited | GH001 | — | COMPLETED | 2024-10-04 | NCT05800860 |
| Alto Neuroscience | ALTO-100 | — | COMPLETED | 2024-09-05 | NCT05712187 |
| Navitor Pharmaceuticals, Inc. | NV-5138 | — | COMPLETED | 2024-08-18 | NCT06235905 |
| Suven Life Sciences Limited | Ropanicant | — | COMPLETED | 2024-07-19 | NCT06126497 |
| Actinogen Medical | Xanamem™ | — | COMPLETED | 2024-07-01 | NCT05657691 |
| Brii Biosciences Limited | BRII-296 | — | COMPLETED | 2024-03-13 | NCT06057012 |
| Denovo Biopharma LLC | Liafensine | — | COMPLETED | 2024-02-06 | NCT05113771 |
| Boehringer Ingelheim | BI 1358894 | — | COMPLETED | 2024-01-10 | NCT04521478 |
| Neurocrine Biosciences | NBI-1065845 | — | COMPLETED | 2024-01-10 | NCT05203341 |
| Novartis | MIJ821 Subcutaneous Injection 1 mg | — | COMPLETED | 2023-11-28 | NCT05454410 |
| Cybin IRL Limited | CYB003 | — | COMPLETED | 2023-10-16 | NCT05385783 |
| Tonix Pharmaceuticals, Inc. | TNX-601 ER | — | COMPLETED | 2023-09-29 | NCT05686408 |
| Beijing Greatway Pharmaceutical Technology Co.,Ltd. | GW117 Tablets | — | COMPLETED | 2023-09-28 | NCT06796868 |
| Xenon Pharmaceuticals Inc. | XEN1101 10 mg | — | COMPLETED | 2023-09-18 | NCT05376150 |
| Ancora Bio, Inc. d/b/a EmbarkNeuro, Inc. | ANC-501 | — | COMPLETED | 2023-08-14 | NCT05439603 |
| Neurocrine Biosciences | NBI-1065846 | — | COMPLETED | 2023-07-07 | NCT05165394 |
| Seelos Therapeutics, Inc. | SLS-002 | — | COMPLETED | 2023-06-17 | NCT04669665 |
| Alto Neuroscience | ALTO-300 oral (PO) tablet | — | COMPLETED | 2023-05-05 | NCT05118750 |
| Alto Neuroscience | ALTO-300 PO Tablet | — | COMPLETED | 2023-04-26 | NCT05157945 |
| Johnson & Johnson | Midazolam | Benzodiazepine [EPC] | COMPLETED | 2023-03-31 | NCT03185819 |
| Alto Neuroscience | ALTO-100 PO Tablet | — | COMPLETED | 2023-01-13 | NCT05419869 |
| Alto Neuroscience | ALTO-100 PO tablet | — | COMPLETED | 2022-12-01 | NCT05117632 |
| Perception Neuroscience | PCN-101 | — | COMPLETED | 2022-11-10 | NCT05414422 |
| Small Pharma Ltd | SPL026 | — | COMPLETED | 2022-10-01 | NCT04673383 |
| Clexio Biosciences Ltd. | CLE-100 | — | COMPLETED | 2022-09-21 | NCT04103892 |
| Praxis Precision Medicines | 10 mg PRAX-114 | — | COMPLETED | 2022-07-15 | NCT04969510 |
| Sirtsei Pharmaceuticals, Inc. | SP-624 | — | COMPLETED | 2022-06-27 | NCT04479852 |
| Neumora Therapeutics, Inc. | NMRA-335140 | — | COMPLETED | 2022-04-08 | NCT04221230 |
| Otsuka Pharmaceutical Co., Ltd. | OPC-64005 20 mg , Once-daily | — | COMPLETED | 2022-02-08 | NCT04244253 |
| GH Research Ireland Limited | 5 Methoxy N,N Dimethyltryptamine | — | COMPLETED | 2021-11-06 | NCT04698603 |
| COMPASS Pathways | Psilocybin | — | COMPLETED | 2021-10-14 | NCT04739865 |
| Johnson & Johnson | JNJ-61393215 | — | COMPLETED | 2021-09-02 | NCT04080752 |
| COMPASS Pathways | Psilocybin | — | COMPLETED | 2021-07-30 | NCT03775200 |
| Axsome Therapeutics, Inc. | AXS-05 | — | COMPLETED | 2021-07-30 | NCT04608396 |
| Johnson & Johnson | JNJ-67953964 | — | COMPLETED | 2020-05-06 | NCT03559192 |
| Sumitomo Pharma America, Inc. | SEP-4199 200 mg | — | COMPLETED | 2020-04-23 | NCT03543410 |
| Novartis | MIJ821 | — | COMPLETED | 2020-03-23 | NCT03756129 |
| Celon Pharma SA | Esketamine DPI - low dose | — | COMPLETED | 2020-03-15 | NCT03965858 |
| Zhejiang Huahai Pharmaceutical Co., Ltd. | Hypidone Hydrochloride tablets | — | COMPLETED | 2019-12-18 | NCT03739632 |
| Minerva Neurosciences | MIN-117 5.0 mg | — | COMPLETED | 2019-11-21 | NCT03446846 |
| Syndeio Biosciences, Inc | AGN-241751 | — | COMPLETED | 2019-10-23 | NCT03726658 |
| VistaGen Therapeutics, Inc. | AV-101 | — | COMPLETED | 2019-10-01 | NCT03078322 |
| Janssen Pharmaceutical K.K. | Intranasal esketamine (28 mg) | — | COMPLETED | 2019-08-19 | NCT02918318 |
| H. Lundbeck A/S | Vortioxetine infusion 25 mg | — | COMPLETED | 2019-07-31 | NCT03766867 |
| Relmada Therapeutics, Inc. | REL-1017 | — | COMPLETED | 2019-07-30 | NCT03051256 |
| Syndeio Biosciences, Inc | AGN-241751 | — | COMPLETED | 2019-07-22 | NCT03586427 |
| Marinus Pharmaceuticals | Ganaxolone | Neuroactive Steroid Gamma-Aminobutyric Acid A Receptor Positive Modulator [EPC] | COMPLETED | 2019-07-05 | NCT03460756 |
| Avid Radiopharmaceuticals | Flortaucipir F18 | — | COMPLETED | 2019-06-26 | NCT02278367 |
| Johnson & Johnson | JNJ-42847922 | — | COMPLETED | 2019-06-13 | NCT03321526 |
| Marinus Pharmaceuticals | Ganaxolone | Neuroactive Steroid Gamma-Aminobutyric Acid A Receptor Positive Modulator [EPC] | COMPLETED | 2019-05-10 | NCT03228394 |
| BioLite, Inc. | PDC-1421 Capsule | — | COMPLETED | 2019-03-12 | NCT02395978 |
| Sponsor | Asset | MoA | Status | Primary Completion | NCT |
|---|---|---|---|---|---|
| Enalare Therapeutics Inc. | ENA-001 | — | RECRUITING | 2026-07-30 | NCT06967259 |
| Otsuka Pharmaceutical Development & Commercialization, Inc. | MSP-2020 | — | RECRUITING | 2027-01-29 | NCT07329621 |
| Sirtsei Pharmaceuticals, Inc. | SP-624 | — | RECRUITING | 2026-04 | NCT06570369 |
| Synphatec (Shanghai) Biopharmaceutical Technology Co., Ltd. | SP-101 injection | — | NOT YET RECRUITING | 2026-06-30 | NCT07334249 |
| Corium Innovations, Inc. | Selegiline Transdermal Delivery System | — | NOT YET RECRUITING | 2026-10-07 | NCT07452692 |
| Soterix Medical | Ketamine (0.25 mg/kg) | — | NOT YET RECRUITING | 2027-12-01 | NCT07307768 |
| Nyree Penn | Diprivan (propofol), Astra-Zeneca | — | NOT YET RECRUITING | 2026-05-01 | NCT06644573 |
| Alar Pharmaceuticals Inc. | ALA-3000 | — | COMPLETED | 2025-12-30 | NCT06965569 |
| Engrail Therapeutics INC | ENX-104 | — | COMPLETED | 2025-11-26 | NCT07253324 |
| Otsuka Pharmaceutical Development & Commercialization, Inc. | SEP-380135 | — | COMPLETED | 2025-09-12 | NCT07549581 |
| Vigonvita Life Sciences | LV232 40mg | — | COMPLETED | 2025-01-19 | NCT06476509 |
| Biogen | Zuranolone | Neuroactive Steroid Gamma-Aminobutyric Acid A Receptor Positive Modulator [EPC] | COMPLETED | 2024-10-18 | NCT05655507 |
| Nanjing Minova Pharmaceutical Co., Ltd. | MI078 | — | COMPLETED | 2024-03-18 | NCT06982651 |
| Brii Biosciences Limited | BRII-297 | — | COMPLETED | 2023-11-21 | NCT05845840 |
| Boehringer Ingelheim | BI 1569912 | — | COMPLETED | 2023-11-16 | NCT04937829 |
| Novartis | MIJ821 | — | COMPLETED | 2023-11-07 | NCT05666687 |
| Small Pharma Ltd | SPL026 | — | COMPLETED | 2023-08-03 | NCT05553691 |
| Jiangsu Nhwa Pharmaceutical Co., Ltd. | NH102 | — | COMPLETED | 2023-04-10 | NCT07324408 |
| Small Pharma Ltd | SPL026 IV | — | COMPLETED | 2023-04-05 | NCT05644093 |
| Syndeio Biosciences, Inc | apimostinel | — | COMPLETED | 2023-04-04 | NCT05597241 |
| Beijing Greatway Pharmaceutical Technology Co.,Ltd. | GW117 ODT | — | COMPLETED | 2023-03-24 | NCT06964711 |
| Johnson & Johnson | Seltorexant Dose 1 | — | COMPLETED | 2023-03-16 | NCT04451187 |
| Jiangsu Hansoh Pharmaceutical Co., Ltd. | HS-10353 | — | COMPLETED | 2023-03-11 | NCT05195203 |
| Seasons Biotechnology (Taizhou) Co., Ltd. | Vortioxetine Hemihydrobromide Orally Disintegrating Tablets 5mg | — | COMPLETED | 2022-11-25 | NCT05416762 |
| Digestome Therapeutics | DGX-001Dose 1 | — | COMPLETED | 2022-11-06 | NCT05121831 |
| Seasons Biotechnology (Taizhou) Co., Ltd. | Vortioxetine Hemihydrobromide Orally Disintegrating Tablets | — | COMPLETED | 2022-10-27 | NCT05416957 |
| Luye Pharma Group Ltd. | LY03010 156 mg treatment group, deltoid | — | COMPLETED | 2022-09-23 | NCT05321602 |
| Seasons Biotechnology (Taizhou) Co., Ltd. | Vortioxetine Hemihydrobromide Orally Disintegrating Tablets | — | COMPLETED | 2022-09-02 | NCT05417087 |
| Soterix Medical | — | — | COMPLETED | 2022-08-10 | NCT04781127 |
| Jiangsu Hansoh Pharmaceutical Co., Ltd. | HS-10345 84mg | — | COMPLETED | 2022-04-30 | NCT05196971 |
| Jiangsu Nhwa Pharmaceutical Co., Ltd. | NH102 | — | COMPLETED | 2022-01-11 | NCT05015192 |
| Jiangsu HengRui Medicine Co., Ltd. | HR071603 | — | COMPLETED | 2021-06-01 | NCT04108234 |
| Zhejiang Huahai Pharmaceutical Co., Ltd. | Hypidone Hydrochloride tablets | — | COMPLETED | 2021-01-11 | NCT04598607 |
| Sunshine Lake Pharma Co., Ltd. | HEC113995 | — | COMPLETED | 2020-08-12 | NCT04623814 |
| Sunshine Lake Pharma Co., Ltd. | HEC113995 PA•H2O tablets | — | COMPLETED | 2019-12-06 | NCT04591301 |
| BioDelivery Sciences International | Belbuca 300 µg | — | COMPLETED | 2019-10-27 | NCT03996694 |
| Boehringer Ingelheim | BI 1358894 | — | COMPLETED | 2019-08-27 | NCT03854578 |
| Navitor Pharmaceuticals, Inc. | NV-5138 | — | COMPLETED | 2019-06-09 | NCT03606395 |
| Johnson & Johnson | JNJ-42847922 20mg | — | COMPLETED | 2019-04-29 | NCT03374475 |
| Luye Pharma Group Ltd. | LY03005 | — | COMPLETED | 2019-02-16 | NCT03822065 |
| Luye Pharma Group Ltd. | LY03005 | — | COMPLETED | 2018-07-17 | NCT03733574 |
| CSPC ZhongQi Pharmaceutical Technology Co., Ltd. | Ammoxetine Hydrochloride Enteric-coated Tablets | — | COMPLETED | 2018-07-11 | NCT03456388 |
| Suven Life Sciences Limited | SUVN-911 | — | COMPLETED | 2018-07-10 | NCT03551288 |
| Johnson & Johnson | Esketamine | — | COMPLETED | 2018-06-29 | NCT02919579 |
| Suven Life Sciences Limited | SUVN-911 | — | COMPLETED | 2018-03-07 | NCT03155503 |
| Luye Pharma Group Ltd. | LY03005 | — | COMPLETED | 2017-12-22 | NCT03357796 |
| Syndeio Biosciences, Inc | zelquistinel | — | COMPLETED | 2017-12-21 | NCT04981561 |
| Lee's Pharmaceutical Limited | Trazodone Hydrochloride prolonged-release tablets | — | COMPLETED | 2017-11-30 | NCT02785601 |
| Lee's Pharmaceutical Limited | trazodone hydrochloride prolonged-release tablet | — | COMPLETED | 2017-11-30 | NCT02785614 |
| Neurocrine Biosciences | TAK-653 | — | COMPLETED | 2017-09-11 | NCT02561156 |
| Johnson & Johnson | JNJ-54175446, 600 mg | — | COMPLETED | 2017-06-02 | NCT02902601 |
| Luye Pharma Group Ltd. | LY03005 | — | COMPLETED | 2016-12-28 | NCT02988024 |
| GSK | Bupropion HCl XL tablet 150mg | — | COMPLETED | 2016-06-29 | NCT02698553 |
| Janssen-Cilag International NV | JNJ-42847922 | — | COMPLETED | 2016-01-04 | NCT02476058 |
| Luye Pharma Group Ltd. | LY03005 extended-release tablets 40 mg | — | COMPLETED | 2015-10-31 | NCT03785652 |
| Roche | Basimglurant | — | COMPLETED | 2015-09 | NCT02433093 |
| Naurex, Inc, an affiliate of Allergan plc | NRX-1074 375 mg | — | COMPLETED | 2015-04 | NCT02366364 |
| Luye Pharma Group Ltd. | LY03005 | — | COMPLETED | 2015-03 | NCT02271412 |
| P1vital Products Limited | — | — | COMPLETED | 2015-01 | NCT02800577 |
| Johnson & Johnson | JNJ-42847922 | — | COMPLETED | 2014-12 | NCT02067299 |
| Johnson & Johnson | Aripiprazole, oral formulation | — | COMPLETED | 2014-10 | NCT02087579 |
| Luye Pharma Group Ltd. | LY03005 | — | COMPLETED | 2014-08 | NCT02055300 |
| Neuralstem Inc. | NSI-189 Phosphate | — | COMPLETED | 2014-02 | NCT01520649 |
| H. Lundbeck A/S | Vortioxetine (Lu AA21004) | — | COMPLETED | 2013-09 | NCT01607125 |
| BioLite, Inc. | PDC-1421 | — | COMPLETED | 2013-07 | NCT01774045 |
| MSI Methylation Sciences, Inc. | Ademetionine | — | COMPLETED | 2013-06-08 | NCT04623034 |
| Otsuka Pharmaceutical Development & Commercialization, Inc. | Brexpiprazole | Atypical Antipsychotic [EPC] | COMPLETED | 2013-05 | NCT01670279 |
| Eli Lilly | LY2216684 | — | COMPLETED | 2012-08 | NCT01460381 |
| Astellas Pharma Inc | FK949E | — | COMPLETED | 2012-06-22 | NCT01919008 |
| Bristol-Myers Squibb | BMS-820836 | — | COMPLETED | 2012-05 | NCT01396252 |
| Eli Lilly | LY2216684 | — | COMPLETED | 2011-12 | NCT01373931 |
| Eli Lilly | LY2216684 | — | COMPLETED | 2011-12 | NCT01460407 |
| Pfizer | desvenlafaxine | — | COMPLETED | 2011-12 | NCT01443208 |
| BlackThorn Therapeutics, Inc. | LY2940094 | — | COMPLETED | 2011-11 | NCT01404091 |
| Neuralstem Inc. | NSI-189 Phosphate | — | COMPLETED | 2011-11 | NCT01310881 |
| Eli Lilly | LY2216684 | — | COMPLETED | 2011-09 | NCT01380691 |
| Eli Lilly | LY2216684 | — | COMPLETED | 2011-09 | NCT01389752 |
| AbbVie | ABT-436 | — | COMPLETED | 2011-09 | NCT01380704 |
| Astellas Pharma Inc | FK949E | — | COMPLETED | 2011-09 | NCT01903200 |
| BlackThorn Therapeutics, Inc. | LY2940094 | — | COMPLETED | 2011-09 | NCT01263236 |
| Eli Lilly | LY2216684 | — | COMPLETED | 2011-08 | NCT01389765 |
| Dong Wha Pharmaceutical Co. Ltd. | DWETR10 | — | COMPLETED | 2011-08 | NCT01367080 |
| Astellas Pharma Inc | FK949E | — | COMPLETED | 2011-05 | NCT01924520 |
| Eli Lilly | LY2216684 | — | COMPLETED | 2011-04 | NCT01241435 |
| Eli Lilly | LY2216684 | — | COMPLETED | 2011-03 | NCT01263197 |
| Eli Lilly | LY2216684 | — | COMPLETED | 2011-03 | NCT01263223 |
| Eli Lilly | Clopidogrel | — | COMPLETED | 2011-03 | NCT01263093 |
| AstraZeneca | AZD6765 | — | COMPLETED | 2011-03 | NCT01046630 |
| Eli Lilly | LY2216684 | — | COMPLETED | 2011-02 | NCT01275144 |
| Eli Lilly | Warfarin | — | COMPLETED | 2011-02 | NCT01263119 |
| Eli Lilly | LY2216684 | — | COMPLETED | 2011-02 | NCT01266590 |
| Eli Lilly | LY2216684 | — | COMPLETED | 2011-01 | NCT01263106 |
| Eli Lilly | LY2216684 | — | COMPLETED | 2011-01 | NCT01243957 |
| Eli Lilly | LY2216684 | — | COMPLETED | 2011-01 | NCT01250873 |
| Pfizer | desvenlafaxine succinate sustained release | — | COMPLETED | 2010-11 | NCT01190514 |
| Bristol-Myers Squibb | BMS-820836 | — | COMPLETED | 2010-11 | NCT00892840 |
| AstraZeneca | — | — | COMPLETED | 2010-10 | NCT01217645 |
| CeNeRx BioPharma Inc. | CX157 | — | COMPLETED | 2010-10 | NCT01633437 |
| GSK | Aripiprazole | Atypical Antipsychotic [EPC] | COMPLETED | 2010-07 | NCT01424449 |
| Novartis | ABP688 | — | COMPLETED | 2010-05 | NCT01528241 |
Novel Drugs by Company (New molecular entities)
Reformulations (24 drugs) Click to expand
Reformulations are FDA-approved versions of existing molecules in new dosage forms (e.g., oral solution vs tablet, extended-release vs immediate-release). They require a new NDA but use an already-proven active ingredient.
Drug Targets
Generic Drugs (9 ANDA approved) Click to expand
Generic drugs contain the same active ingredient as the brand-name drug and are approved via ANDA (Abbreviated New Drug Application).
Drug Categories:
- Novel Drugs: NDA Type 1/2 (new molecular entity) or original BLA
- Reformulations: NDA Type 3/5 (new dosage form of existing molecule)
- Biosimilars: BLA-approved biologics highly similar to reference products
- Generics: ANDA-approved copies of small molecule drugs